PREPARED UNDER THE AUSPICES OF THE WEST AFRICA AGRICULTURE PRODUCTIVITY PROGRAMME
(WAAPP)
FOR USE BY PESTICIDE REGISTRATION EXPERTS
ENVIRONMENTAL PROTECTION AGENCY CHEMICALS CONTROL AND MANAGEMENET CENTRE
ACCRA
JUNE 2012
GUIDELINES FOR EVALUATION OF PESTICIDE BIO EFFICACY
TRIAL REPORTS
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Table of content
1.0 Introduction .............................................................................................................................. 3
1.1 Purpose of this guide .................................................................................................................. 3
1.2 Scope .......................................................................................................................................... 4
2.0 Efficacy of a pesticide ................................................................................................................ 5
3.0 Principles for assessing acceptability of efficacy ........................................................................ 6
3.1 Sources of information ............................................................................................................... 6
3.2 Scanning of data submissions .................................................................................................... 6
3.3 Assessing the appropriateness and adequacy of the data ......................................................... 7
4.0 Test Procedures .......................................................................................................................... 8
4.1 Acceptability of the studies: ....................................................................................................... 8
4.2 Location, duration and number of tests: .................................................................................... 8
4.3 Effectiveness: ............................................................................................................................. 9
4.4 Direct efficacy ............................................................................................................................. 9
4.5 Comparison with the untreated control .................................................................................... 9
4.6 Comparison with a reference product ..................................................................................... 10
4.7 Comparison with other pest management approaches ........................................................... 10
4.8 Crop tolerance .......................................................................................................................... 11
5.0 Agronomic sustainability .......................................................................................................... 12
5.1 Resistance ................................................................................................................................ 12
5.2 Effects on succeeding crops ..................................................................................................... 12
5.3 Effects on adjacent crops ......................................................................................................... 12
5.4 Effects on non-‐target organisms .............................................................................................. 13
6.0 Conclusion on efficacy evaluation ............................................................................................ 14
7.0 Appendix I ................................................................................................................................ 15
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1.0 Introduction These guidelines describe the general requirements and the format to be used
for the assessment of an efficacy trial report submitted in support of registration
of pesticides.
In conducting efficacy trials, applicants are expected to demonstrate that when
the product is used in accordance with label directions, it is effective for the
purposes claimed and that application to the indicated plant or situation will not
cause any unintended effect.
Where the data submitted does not adequately support registration, additional
data will be required. In some cases, data would be rejected. Efficacy should
be demonstrated for every host and pest claimed on the label. Limited
extrapolation to other pests and hosts may be accepted with prior approval from
the registration authority.
The purpose of the efficacy review is to ensure that the proposed use of a
pesticide product is supported by adequate scientific information. For a
treatment to be acceptable for registration, the information submitted must
prove that the proposed treatment is effective in pest control and safe to the
host.
1.1 Purpose of this guide
The intent of these guidelines is to establish procedures and criteria for efficacy
data evaluation by regulatory officers authorized to carry out assessment of
pesticide efficacy reports. The aim of this guideline is to ensure standardized
procedures for the assessment so as to eliminate the potential for uncertainty
and confusion of decision regarding the approval process for trials. They also
assist the registrants in their understanding of the review process and the basis
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for acceptance or rejection of a proposed registration. It should be noted that
these guidelines provide general guidance only, rather than a check list or rigid
criteria. Scientific judgment should be exercised in using them in assessing a
particular efficacy report
1.2 Scope
These guidelines concern efficacy assessment of conventional chemical
pesticides only. However, it may be applied in limited extent to biological,
microbial or botanical pest control agents. The circumstance must be clearly
described.
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2.0 Efficacy of a pesticide
For the purpose of this guidelines, the efficacy of a pesticide product in
agriculture, forestry, public health and other use situations can be defined as a
measure of the overall effect of its application on the intended agricultural,
forestry etc system in which it is used. Thus testing for the efficacy of a
pesticide product, could result both in a positive effect (that is controlling the
target pest or modifying crop growth in order to achieve improvement in the
quantity and/or quality of crop yield, premature or delayed ripening), and a
negative effect, (such as reduction of quality or quantity of yield/phytotoxicity,
damage to beneficial organisms, damage to succeeding or adjacent crops,
development of resistance). There are other aspects of efficacy which,
depending on the product, can be either positive or negative; these include
effects on other non-target pests, length of time in which the product continues
to be active, ease of its use, and compatibility with other cultural practices and
crop protection measures. The net result of the positive and negative effects
should be a sufficient overall benefit in order to justify the use of the product.
In testing for efficacy other parameters such as crop safety, phytotoxicity,
resistance, yield quality and quantity of yield should also be assessed and
reported.
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3.0 Principles for assessing acceptability of efficacy
After a biological dossier has been submitted to the registration authority as part
of the request for authorization of the plant protection product, an evaluation
has to be made as to the acceptability of the product for the proposed use
pattern. This assessment is made by the registration authority.
A number of general principles will always need to be addressed when
evaluating a biological dossier and deciding on the acceptability of the product.
3.1 Sources of information
It is the responsibility of the registrant to produce, collect and submit all
scientific information required to support the proposed registration. However,
the Product Managers may use any relevant data available to them in addition to
those submitted by the registrant. They may base their judgement on their own
experience and knowledge of the pesticide product under consideration. They
may also consult with research scientists and/or other personnel involved in the
research being reviewed. It must be remembered, however, that only "scientific
evidence" will be used in the assessment of the performance of a product.
Testimonials from individuals, without documented evidence, are of no value in
efficacy evaluation.
3.2 Scanning of data submissions
The registrant's submission should include all information necessary to provide
a complete evaluation of the usefulness of a product. The evaluation expert
examines the complete data package and a judgement will be made as to
whether any data omissions are significant enough to adversely affect the
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review. Those so identified should be communicated back to the registrant for
supplemental data submissions before the evaluation can be carried out.
3.3 Assessing the appropriateness and adequacy of the data
If there are no apparent major data gaps which would prevent a meaningful
evaluation of the submission, the reviewer will then consider the
appropriateness of the submission, i.e., the intended use pattern and adequacy of
the data that has been supplied. The following items should be considered in the
assessment:
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4.0 Test Procedures
Test procedures employed in developing data to support the registration of a
control product will vary according to the characteristics of the chemical, the
type of formulation, the target pest, the use pattern, the methods and timing of
application, and many other factors. However, there are certain basic principles
and techniques that should be employed in carrying out the efficacy trials and
certain information must be reported in support of registration of a use claim.
4.1 Acceptability of the studies:
The acceptability of a test is evaluated on the basis of whether it is designed and
conducted following acceptable test procedures. Elements for consideration
may include test material, test species, site of test, method and rate and timing
of application, etc.
4.2 Location, duration and number of tests:
For field studies, the geographic distribution of the tests should adequately
cover the various climate and soil conditions likely to be encountered. The
duration of testing (number of years) should be long enough to reflect
fluctuations and variances of conditions that normally occur from year to year.
Generally, a minimum of two years is required. The number of tests should be
large enough to produce conclusive results with a high degree of confidence. It
depends on many factors, such as pest/host combinations, the proposed use
situation, and the consistency (reproducibility) of the results.
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4.3 Effectiveness:
The data should demonstrate that the pesticide product, when used as directed,
will have merit and value such as increases in marketable yields of desirable
quality, a reduction of damage, a satisfactorily high degree of repellency or
attraction, reduction of injury, or reduction of the pest population to acceptable
low levels. The acceptable level of control may vary depending on the purpose
of the proposed use.
4.4 Direct efficacy
Various parameters should be taken into account when evaluating the
acceptability of the direct efficacy or effectiveness of a plant protection product.
4.5 Comparison with the untreated control
The product will always have to show results (e.g. level, duration and
consistency of control of or protection against a pest) that are significantly
superior to those recorded in the untreated control.
It is not possible to set generally applicable levels of control that should be
achieved. In some cases, relative low efficacy levels (e.g. 50 – 70%) may
already provide benefits to the grower. Lower levels of control may also be
acceptable if the product has little or no effects on natural enemies of pests and
can therefore be incorporated into an IPM approach. In other cases, a high level
of control may be required, for instance in the case of epidemic pests that can
produce extensive damage or for pests that cause direct damage to the
marketable portion of a crop (e.g. extensive blemishing on fruits).
The principal criterion is that the product must produce a clear and meaningful
(commercial) benefit to the grower.
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If no comparison with a reference product is available, this will be the only
criterion that can be used to assess the acceptability of direct efficacy.
4.6 Comparison with a reference product
The efficacy of the product should normally be comparable to or better than that
of an appropriate reference product. The reason for this is to prevent products
that have a clearly lower efficacy than already available products to come onto
the market. Such products are more likely to be overdosed and so increase
exposure of humans or the environment.
However, there are various valid reasons for authorizing a product with a lower
efficacy for use in a country. This may occur when other characteristics of the
product have advantages over the reference product or over other products
registered for the same use. This may be justified if the new product:
• Can be used over a wider range of growth stages of the crop;
• Is efficacious against more pest stages;
• Is efficacious against more pest species;
• Is less influenced by climatic factors or soil type;
• Has greater compatibility with cultural practices or other plant protection
measures (e.g. IPM);
• Has a lower probability of causing resistance;
• Has fewer undesirable side-effects (e.g. on beneficial organisms, other
crops).
4.7 Comparison with other pest management approaches
Whenever possible, the efficacy of a new plant protection product should also
be compared with other pest management approaches than the use of chemical
plant protection products. This includes, but is not limited to, the use of resistant
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varieties, cultural or agronomic pest management measures, biological control
or IPM.
While the comparison of efficacy of a plant protection product with an entirely
different pest management technique may not always be straightforward, such
assessments should be done whenever feasible, to evaluate the overall benefits
of registering a new product.
4.8 Crop tolerance
The use of the plant protection product should not result in unacceptable
phytotoxic effects on the crop itself. It should not result in an unacceptable
reduction in the yield of the crop, and definitely not beyond that what would
have occurred without use of the plant protection product (note that in cases of
quality improvement, a reduction in yield may sometimes be acceptable).
Similarly, there should not be an unacceptable adverse effect on the quality of
the crop or its produce, nor on treated plants or plant parts used for propagation.
In certain cases, what are originally unacceptable effects can be mitigated by
appropriate measures, and thus become acceptable (e.g. by using specific
application equipment, avoiding treatment at particular times during crop
growth). In such a case, the registration authority should always appraise to
what extent the proposed risk mitigation measures can be realistically applied
and respected under the national conditions of use. If realistically the measure
cannot be implemented, a decision not to register the product may need to be
taken.
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5.0 Agronomic sustainability
5.1 Resistance
The (over) use of one single product, or a combination of products, that has a
clear risk of resistance development is generally undesirable. A resistance
management scheme should then be formulated by the registrant to effectively
delay the development of resistance.
The registration authority should always appraise to what extent the proposed
resistance management scheme can be realistically applied and respected under
the national conditions of use. If realistically the scheme cannot be fully
implemented, a decision not to register the product may need to be taken.
5.2 Effects on succeeding crops
Generally, a high risk of adverse effects of the product on succeeding crops,
including substitute crops, is not acceptable. In a few cases, label warnings or
other mitigation measures may be proposed that can reduce the risk to an
acceptable level (e.g. if no alternative plant protection product or pest control
measure is available, or if there is only a risk for certain substitute crops that are
directly sown after crop failure).
The registration authority should always apprise to what extent the proposed
measures to limit the risk to succeeding crops can be realistically applied and
respected under the national conditions of use. If realistically they cannot be
fully implemented, a decision not to register the product may need to be taken.
5.3 Effects on adjacent crops
The use of the plant protection product should not result in unacceptable effects
on adjacent crops unless the risk of such effects can be minimized using
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appropriate measures (e.g. use of drift reduction measures, leaving unsprayed
barriers).
The registration authority should always appraise to what extent the proposed
measures to limit the risk to adjacent crops can be realistically applied and
respected under the national conditions of use. If realistically they cannot be
implemented, a decision not to register the product may need to be taken.
5.4 Effects on non-‐target organisms
The evaluation of the acceptability of any risk to non-target organisms is
normally taken as part of the evaluation of the environmental dossier. The
possible observations of adverse effects encountered in efficacy trials should be
taken into consideration during that evaluation.
Products that have a major effect on natural enemies of the crop pest will
arguably not contribute to sustainable crop protection and may not be
acceptable from an agronomic point of view. In particular, when specific claims
are being made with respect to the use of the product in IPM schemes, the
product should not have unacceptable effects on the natural enemies of the pests
covered in the IPM scheme. Similarly, if the product is to be used on blooming
crops, or otherwise in periods when pollinators may be exposed, it should not
have unacceptable adverse effects on these pollinators, unless mitigation
measures can be realistically applied.
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6.0 Conclusion on efficacy evaluation
Appendix I should be used to summarise the review process and the decision of
the reviewer. In general, based on the review of all scientific information
available, the evaluation officer will decide whether the proposed use of a
product is acceptable for registration from the efficacy point of view:
(a) The proposed registration is acceptable if the data demonstrate an adequate
level of pest control without unacceptable effect to the host and support all the
label claims and statements;
(b) If the proposed registration is not fully supported by available data, changes
to the draft label may be made, in consultation with the registrant, to improve
use directions and precautions. Acceptance of the registration may then be
considered based on the revised draft label; or
(c) If additional data/information are required to support claims and to resolve a
particular point or item of concern, the evaluation officer will identify the
additional requirements and notify the registrant.
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7.0 Appendix I
Environmental Protection Agency
Reporting Form for Pesticide Efficacy Trial Evaluation
Name of Evaluation Expert…………………………….Designation…………………………………
Department or Organization……………………………Trial reference number……………………..
Date received ………………………………………. Date submitted…………………………….
For each section please give brief
comments. Otherwise indicate acceptability
by Y or N as appropriate. (Please refer to
guideline)
A Background information on test product
Commercial name of product under trial:
Product active substance(s)
Formulation
Product classification
Manufacturers/product ownership
B Testing unit
Name of efficacy testing organization/
facility
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Location where trial was conducted.
Soil type
Scientist in charge of trial.
Number of trials
Number of seasons trial was conducted
Reference product(s) (justification for
use)
Plot size and replication
Treatments
Trial methodology
Trial protocol used
Date and season of trial
C Trial category
Single product or Mixtures
Field trial, laboratory, glasshouse, (please
indicate)
Storage trials or public health
D Conformity of trial to label claim.(please indicate whether the above parameters
conform to label instructions)
Objective of trial
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Target crop
Target pest
Application equipment, spray
quality/nozzle type, pressure (kPa, bar);
The amount (i.e. dose) of the pesticide
product ie application rate(l/ha)
Crop growth stage at application;
The number, frequency and timing of the
applications;
Method of application
If required on the label, the amount of
adjuvant added.
E Efficacy parameters. Please indicate the extent to which the underlisted parameters
have been addressed
Direct efficacy (effectiveness)
Risk of resistance
Absence of unacceptable effects on plants
or plant products
v Phytotoxicity
v Yield
v Quality
v Absence of unacceptable effects
on production and production
systems, in particular on
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pollinators and natural enemies.
F Assessment of trial
Has trial been conducted under Good
Agricultural Practice (GAP)?
Was the proposed level of control
achieved?
Did the product show results that are
significantly equal or superior to those
recorded in the untreated control?
Extent of reduction of pest level or
damage (eg below an economic or
phytosanitary threshold).
Is the performance of the test product
comparable to that of the reference
product?
If an effective minimum dose level has
been proposed, is there enough
justification to effect a modification of
label claims. Please explain the basis for
acceptance or otherwise of proposed
minimum effective dose from trial
G Conclusion
The acceptability of the trials
organizations, test methods and location
of testing;
The extent, quality and consistency of the
data
The acceptability of any uses supported
by evidence other than trials data
-uses recommended for authorization
-uses not recommended for authorization
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Any restrictions on use
Any particular comments on the
conditions relevant to or limitations on the
use of the product in the region and claim
for which use is sought.
Changes to product label
Statistical analysis
H Recommendation for registration. Please indicate reasons for your recommendations
and any additional comments on report/label etc(use overleaf)
Approved
Suspend
Deny
Additional data required